CClinicalTrials.gg
Status unknownNCT05520216Updated Sep 2, 2022

Effect of Rib Cage and Spine Mobility on Maximum Breath-Hold Time

An observational study in Healthy Participant, sponsored by Saglik Bilimleri Universitesi. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Saglik Bilimleri Universitesi · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
82
Ages
18 Years to 25 Years
Sex
All
01

Study summary

In this study, it was aimed to look at the effect of rib cage and spine mobility on maximum breath holding time. To determine the relationship between spine and rib cage mobility level and respiratory capacity.

Read the detailed description

The demographic information of the participants (gender, age, height, body weight, body mass index, occupation, dominant extremity, education level, marital status) will be questioned with the Demographic Data Form to be created by the researchers. Except for the demographic data form, the breath-holding capacity of the participants will be evaluated by measuring the breath-holding times, and the thoracic cage mobility will be evaluated by measuring the chest circumference during normal respiration, maximal inspiration and maximal expiration. The curvature of the spine, the presence of kyphosis and lordosis will be measured using the Spinal Mouse (IDIAG m360) device, which is an objective measurement method. The flexibility of the spine and indirectly the mobility of the rib cage will be checked with the sit and lie test. The results of the evaluations will be recorded.

A consent form stating that they are healthy female and male volunteer participants aged between 18-25 years old and who meet the inclusion criteria will be filled in to participate in the study. After the consent form is signed, clinical evaluations will begin.

Study Design: Experimental nonrandomized field study

02

Conditions studied

  • Healthy Participant

Keywords

  • Maximum breath hold test
  • Spinal Mouse
  • Mobility
03

In context

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

asymptomatic individual

Inclusion criteria

  • Being between the ages of 18-25
  • Being cooperative
  • Those who want to participate in the study voluntarily

Exclusion criteria

Exclusion Criteria:

  • Having had any lower extremity or spine surgery
  • Having a vestibular system disorder
  • Pregnancy or the possibility of pregnancy
  • Known, diagnosed spinal cord, visceral, or other musculoskeletal disorders
  • Refusal to participate in the study
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
82 participants (estimated)
Patient registry
No

Groups and cohorts

  • asymptomatic individuals

    The demographic information of the participants (gender, age, height, body weight, body mass index, occupation, dominant extremity, education level, marital status) will be questioned with the Demographic Data Form to be created by the researchers. Except for the demographic data form, the breath-holding capacity of the participants will be evaluated by measuring the breath-holding times, and the thoracic cage mobility will be evaluated by measuring the chest circumference during normal respiration, maximal inspiration and maximal expiration. The curvature of the spine, the presence of kyphosis and lordosis will be measured using the Spinal Mouse (IDIAG m360) device, which is an objective measurement method. The flexibility of the spine and indirectly the mobility of the rib cage will be checked with the sit and lie test. The results of the evaluations will be recorded.

    Device: Spinal mouse (idiag m360) · Behavioral: chest circumference measurement · Behavioral: Maximum Breath Hold Test · Behavioral: Sit and Reach

Interventions

  • DeviceSpinal mouse (idiag m360)

    A noninvasive Spinal Mouse device will be used to measure the thoracic kyphosis and lumbar lordosis angle of the spinal column in the sagittal plane. It will be displayed on the computer aided software screen where the thoracic and lumbar region angles are calculated by swiping over the spinal processes from top to bottom with the Spinal Mouse (IDIAG m360) device. Measurements will be taken while standing on a flat surface. The volunteer will take off his upper clothes and shoes during the examination. Relax your arms and torso will be positioned next to you. The distance between the feet will be approximately waist width and parallel to each other, the knees will be straight and face motionless. He will stand where he feels comfortable. A Spinal Mouse examination will be performed and data will be recorded.

  • Behavioralchest circumference measurement

    Measurements will be taken from the axillary (4th rib level - two fingers below the axilla), epigastric (xiphoid process level) and subcostal (9th rib level) regions at the time of normal, maximal inspiration, and maximal expiration using a tape measure while the patient is in a sitting position. The tape measure will be placed in the area to be measured. Care will be taken that there is no folding or horizontal level difference in the tape measure and that the fingers are not under the tape measure. Normal respiration will be measured first and recorded in centimeters (cm). The patient will then be asked to take a deep, long breath towards the bottom of the tape measure. The value obtained will be recorded as the deep inspiration value. Immediately after deep inspiration, the patient will be asked to make a deep and long expiration. The obtained value will be recorded as deep expiration.

  • BehavioralMaximum Breath Hold Test

    During the breath-hold measurement, the subject will sit in a chair with a backrest. He will take a deep breath through his nose. We do not want maneuvers (Valsalva and Müller) and diaphragm contractions that will affect the breath-hold time, so volunteers will be observed throughout the test. The test will be terminated as soon as involuntary diaphragm contractions are seen. This test will be applied 3 times by resting the volunteer with breaks for 5 minutes. The average of 3 test results will be taken (Lin, Y. C.: Effect of O2 and CO2 on breath hold breaking point. In The Physiology of Breath Hold Diving. (eds): CEG Lundgren, M Ferringo, Undersea and Hyperbaric Medical Society Inc, Bethesda, Maryland, p: 75-87 1987.).

  • BehavioralSit and Reach

    While the participant is sitting on the floor with his back to the wall and his legs are fully extended in front of him, his knees should be in full contact with the floor. The box will be placed on the sole of the participant's feet (without shoes) in full contact with the volunteer's feet. The participant will be instructed to lean forward as slowly as possible, keeping their fingertips level with each other and their legs straight on the floor. He will be asked to slowly lie down along the ruler three times, and on the third attempt the volunteer will be instructed to reach out as far as possible and hold for 2 seconds. This value will be saved

06

What researchers measure

Primary outcomes

  1. Maximum breat-hold time

    In conclusion, in this study, a significant relationship was found between maximum breath holding time and age, BMI, and smoking.

    Time frame: 20 05 2022

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Masaki M, Ogawa Y, Inagaki Y, Sato Y, Yokota M, Maruyama S, Takeuchi M, Kasahara M, Minakawa K, Okamoto M, Chiyoda Y, Mino K, Aoyama K, Nishi T, Ando Y. Association of sagittal spinal alignment in the sitting position with the trunk and lower extremity muscle masses in children and adults with cerebral palsy: A pilot study. Clin Biomech (Bristol). 2021 Dec;90:105491. doi: 10.1016/j.clinbiomech.2021.105491. Epub 2021 Sep 25. PubMed 34597916 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05520216
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Sep 20, 2022 (estimated)
Primary completion
Jan 20, 2023 (estimated)
Completion
Dec 20, 2023 (estimated)
Last update
Sep 2, 2022

Study contacts

Esra PEHLİVAN
Contact
esra.pehlivan@sbu.edu.tr
0216 346 36 36 ext. 2615
Duygu DEMİR
principal investigator · Saglik Bilimleri University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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